Juvenile Idiopathic Arthritis Clinical Trial
— OSE-JIAOfficial title:
Oxidation Rates of the Different Substrates During Exercise in Children and Adolescents With Juvenile Idiopathic Arthritis. Case-control Study and Cases Treated / Cases Not Treated With Anti-TNFα
During exercise, energy comes mainly from carbohydrates and lipids. The relative
contribution of lipids and glucose as energy substrates to exercise depends on the
parameters of the exercise (duration, intensity and level of training) and the physiological
conditions of the subject.
Inflammatory diseases such as juvenile idiopathic arthritis (JIA) are treated, for the most
severe forms, by biotherapies. These treatments target certain pro-inflammatory cytokines
including TNFα. In adults with rheumatoid arthritis several studies have shown that
treatment with anti-TNFα increases insulin sensitivity. There is no data on the oxidation of
energy substrates during exercise in children and adolescents with AJI, nor on the impact of
anti-TNFα treatments on the oxidation of energetic substrates in children.
Investigators hypothesize that, compared to healthy children, children with JIA should
exhibit altered oxidation of energy substrates at rest and submaximal physical exercise due
to physical deconditioning and inflammation. In addition, those treated with anti-TNFα
should have an oxidation profile of energy substrates at exercise different from that of
patients not treated with anti-TNFα. Investigators also hypothesize that anti-TNFα
treatments modify the contribution of energy chains (aerobic, anaerobic and anaerobic
alactic) during the exercise.
| Status | Recruiting |
| Enrollment | 66 |
| Est. completion date | September 2020 |
| Est. primary completion date | May 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 8 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Children with juvenile idiopathic arthritis Exclusion Criteria: - active infection - BMI > 25 - Systemic corticosteroid within last 3 months |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermon-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage variation of the maximal fat oxidative rate during an exercise between JIA and healthy children. Timing: | at day 1 (first test) | Yes | |
| Secondary | Percentage variation of substrates oxidative crossing point during an exercise. | at day 1 | Yes | |
| Secondary | Description of the contribution of energy systems during supra-maximal physical exercise | Description of the contribution of energy systems during supra-maximal physical exercise in patients with JIA according to JIA subtype, treatments, age, pubertal status, disease status | at day 1 (first test) | Yes |
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